ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
medimedia.ir

Pegylated interferon (peginterferon) beta-1a: Drug information

Pegylated interferon (peginterferon) beta-1a: Drug information
(For additional information see "Pegylated interferon (peginterferon) beta-1a: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Plegridy;
  • Plegridy Starter Pack
Brand Names: Canada
  • Plegridy
Pharmacologic Category
  • Biological Response Modulator;
  • Interferon
Dosing: Adult
Multiple sclerosis, relapsing

Multiple sclerosis, relapsing: IM, SUBQ: Initial: 63 mcg on day 1; 94 mcg on day 15. Maintenance: 125 mcg every 14 days beginning on day 29. Note: Analgesics and/or antipyretics may help decrease flu-like symptoms during treatment.

Conversion between IM and SUBQ routes: Switching between routes has not been studied; however, repeating dose titration is not expected to be needed to decrease flu-like symptoms when switching routes, since bioequivalence has been demonstrated between IM and SUBQ administration.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; use with caution in severe renal impairment (CrCl <30 mL/minute).

Hemodialysis: Partially removed (~24%) by hemodialysis

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, not metabolized extensively in the liver.

Dosing: Adjustment for Toxicity: Adult

Pulmonary arterial hypertension: Discontinue treatment with confirmed diagnosis.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.

>10%:

Local: Erythema at injection site (62%), injection-site pruritus (13%), injection-site reaction (66%; severe: 3%), pain at injection site (15%)

Nervous system: Asthenia (13%), chills (17%), headache (44%)

Neuromuscular & skeletal: Arthralgia (11%), myalgia (19%)

Respiratory: Flu-like symptoms (47%)

Miscellaneous: Fever (45%)

1% to 10%:

Dermatologic: Pruritus (4%)

Gastrointestinal: Nausea (9%), vomiting (5%)

Hematologic & oncologic: Decreased white blood cell count (<3 × 109/L: 7%)

Hepatic: Increased gamma-glutamyl transferase (3%), increased serum alanine aminotransferase (6%; >5 × ULN: 2%), increased serum aspartate aminotransferase (4%)

Immunologic: Antibody development (to PEG: 7%; neutralizing antibodies: <1%)

Local: Hematoma at injection site (3%), rash at injection site (2%), swelling at injection site (3%), warm sensation at injection site (3%)

Nervous system: Hyperthermia (4%), increased body temperature (6%), pain (5%)

<1%:

Dermatologic: Urticaria

Hematologic & oncologic: Pancytopenia, severe neutropenia, severe thrombocytopenia

Hepatic: Increased serum bilirubin

Hypersensitivity: Angioedema

Local: Tissue necrosis at injection site

Postmarketing:

Hematologic & oncologic: Hemolytic-uremic syndrome, thrombotic microangiopathy, thrombotic thrombocytopenic purpura

Hepatic: Hepatic injury (severe; including autoimmune hepatitis, hepatic failure, hepatitis [including noninfectious])

Hypersensitivity: Anaphylaxis, severe hypersensitivity reaction

Respiratory: Pulmonary hypertension (pulmonary arterial hypertension)

Contraindications

Hypersensitivity to natural or recombinant interferon beta or peginterferon, or any component of the formulation.

Canadian labeling: Additional contraindications (not in US labeling): Current severe depression and/or suicidal ideation.

Warnings/Precautions

Concerns related to adverse effects:

• Autoimmune disorders: Idiopathic thrombocytopenia, hyper- and hypothyroidism, and autoimmune hepatitis have been reported. Consider discontinuing treatment in patients who develop a new autoimmune disorder.

• Bone marrow suppression: May cause decreased peripheral blood cell counts in all cell lines, including rare instances of pancytopenia and severe thrombocytopenia. Monitor CBC with differential and platelets; monitor patients for infections, bleeding, and symptoms of anemia. Patients with preexisting myelosuppression may need more intensive monitoring.

• Hepatic effects: Severe hepatic injury, including hepatitis, autoimmune hepatitis, and severe hepatic failure (rare) have been reported; asymptomatic elevation of hepatic transaminases has also been reported and has recurred upon rechallenge. Monitor for signs and symptoms of hepatic injury.

• Hypersensitivity: Anaphylaxis and other serious allergic reactions (eg, angioedema, urticaria) may occur (rare); discontinue therapy if a serious allergic reaction occurs and institute appropriate supportive therapy.

• Injection-site reactions: Injection-site reactions have occurred, including pain, erythema, edema, pruritus, cellulitis, abscess, and necrosis. Necrosis may occur at single and multiple sites. Some reactions have occurred ≥2 years after initiation with use of other interferon beta products; reactions typically resolve with conservative treatment (antibiotics or surgical intervention may be required). Patient and/or caregiver competency in injection technique should be confirmed and periodically reevaluated. Do not inject into affected area until completely healed; if multiple lesions occur, discontinue use until they are fully healed.

• Neuropsychiatric disorders: Depression, suicidal ideation and suicide have been reported; monitor for symptoms of depression and suicidal ideation; consider discontinuing treatment with development of depression or other severe psychiatric symptoms.

• Pulmonary effects: Pulmonary arterial hypertension (sometimes requiring hospitalization and one patient requiring a lung transplant) has occurred in patients without other risk factors taking interferon beta products; onset varies and may occur several years after initiation of treatment. Patients with unexplained symptoms (eg, dyspnea, new or worsening fatigue) should be evaluated for pulmonary arterial hypertension.

• Thrombotic microangiopathy: Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura (TTP) or hemolytic uremic syndrome (HUS), has been reported (some fatal) with interferon beta products. Cases have been reported several weeks to years after initiating therapy. Monitor for new-onset hypertension, thrombocytopenia, renal impairment; discontinue use in patients who develop TMA and manage appropriately (Hunt 2014; Mahe 2013).

Disease-related concerns:

• Cardiovascular disease: Congestive heart failure (CHF), cardiomyopathy, and cardiomyopathy with CHF may occur in patients receiving interferon beta. Monitor patients with significant cardiac disease for worsening of their cardiac condition during initiation and continuation of therapy.

• Renal impairment: Use with caution in severe renal impairment; increased drug exposure may occur; monitor for adverse reactions.

• Seizures: May cause seizures; use with caution in patients with a seizure disorder.

Dosage form specific issues:

• Latex: The protective rubber cover of the IM prefilled syringe may contain latex.

• Product variability: Due to differences in dosage, patients should not change brands of interferon.

Product Availability

Plegridy 125 mcg/0.5 mL prefilled syringe for intramuscular administration: FDA approved January 2021; anticipated availability currently unknown.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Pen-injector, Subcutaneous [preservative free]:

Plegridy: 125 mcg/0.5 mL (0.5 mL) [contains mouse (murine) and/or hamster protein]

Plegridy Starter Pack: 63 mcg/0.5 mL & 94 mcg/0.5 mL (1 mL) [contains mouse (murine) and/or hamster protein]

Solution Prefilled Syringe, Intramuscular [preservative free]:

Plegridy: 125 mcg/0.5 mL (0.5 mL)

Solution Prefilled Syringe, Subcutaneous:

Plegridy: 125 mcg/0.5 mL (0.5 mL) [contains mouse (murine) and/or hamster protein]

Plegridy Starter Pack: 63 mcg/0.5 mL & 94 mcg/0.5 mL (1 mL) [contains mouse (murine) and/or hamster protein]

Generic Equivalent Available: US

No

Pricing: US

Solution Pen-injector (Plegridy Starter Pack Subcutaneous)

63 & 94 mcg/0.5 mL (per mL): $9,919.01

Solution Pen-injector (Plegridy Subcutaneous)

125 mcg/0.5 mL (per 0.5 mL): $4,959.50

Solution Prefilled Syringe (Plegridy Intramuscular)

125 mcg/0.5 mL (per 0.5 mL): $4,959.50

Solution Prefilled Syringe (Plegridy Starter Pack Subcutaneous)

63 & 94 mcg/0.5 mL (per mL): $9,919.01

Solution Prefilled Syringe (Plegridy Subcutaneous)

125 mcg/0.5 mL (per 0.5 mL): $4,959.50

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Subcutaneous:

Plegridy: 125 mcg/0.5 mL (0.5 mL)

Solution Therapy Pack, Subcutaneous:

Plegridy: 63 mcg/0.5 mL & 94 mcg/0.5 mL (1 mL)

Administration: Adult

A health care professional should provide preparation/administration training to patient or caregiver prior to the first dose. Allow product to warm to room temperature (~30 minutes) prior to administration; do not heat using external sources (eg, hot water).

IM: Administer IM in the thigh; rotate injection sites between left and right thigh.

SUBQ: Administer SUBQ in the abdomen, back of the upper arm, or thigh; rotate injection sites; do not inject into area where skin is red, irritated, bruised, infected, or scarred.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125499s028lbl.pdf#page=20, must be dispensed with this medication.

Use: Labeled Indications

Multiple sclerosis, relapsing: Treatment of patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease

Medication Safety Issues
Sound-alike/look-alike issues:

Peginterferon beta-1a may be confused with interferon alfa-2b, interferon alfacon-1, interferon beta, interferon gamma-1b, peginterferon alfa-2a, peginterferon alfa-2b

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Cladribine: May enhance the adverse/toxic effect of Interferons (Beta). Specifically, the risk for lymphopenia may be increased. Risk X: Avoid combination

Pegloticase: May diminish the therapeutic effect of PEGylated Drug Products. Risk C: Monitor therapy

Pegvaliase: PEGylated Drug Products may enhance the adverse/toxic effect of Pegvaliase. Specifically, the risk of anaphylaxis or hypersensitivity reactions may be increased. Risk C: Monitor therapy

Zidovudine: Interferons may enhance the adverse/toxic effect of Zidovudine. Interferons may decrease the metabolism of Zidovudine. Risk C: Monitor therapy

Reproductive Considerations

In general, disease modifying therapies for multiple sclerosis (MS) are stopped prior to a planned pregnancy except in females at high risk of MS activity (AAN [Rae-Grant 2018]). Consider use of agents other than peginterferon beta-1a for females at high risk of disease reactivation who are planning a pregnancy. Delaying pregnancy is recommended for females with persistent high disease activity; when disease modifying therapy is needed in these patients, other agents are preferred (ECTRIMS/EAN [Montalban 2018]).

Pregnancy Considerations

Information related to the use of peginterferon beta-1a in pregnancy is limited (MacDonald 2018). Based on available data, an increased risk of major birth defects following maternal use of interferon beta products has not been observed; data related to low birth weight or miscarriage are inconsistent.

In general, disease-modifying therapies for multiple sclerosis (MS) are not initiated during pregnancy, except in females at high risk of MS activity (AAN [Rae-Grant 2018]). When disease-modifying therapy is needed in these patients, other agents are preferred (ECTRIMS/EAN [Montalban 2018]).

Breastfeeding Considerations

It is not known if peginterferon beta-1a is present in breast milk; however, interferon beta-1a is present in breast milk following use of other products.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Monitoring Parameters

CBC with differential and platelets, transaminase levels; signs and symptoms of hepatic injury, hypersensitivity, infections, bleeding, new onset autoimmune disorders, psychiatric disorders (including depression and/or suicidal ideation), new onset/worsening cardiovascular disease; signs/symptoms of injection-site reactions; assess patients who develop unexplained symptoms (eg, dyspnea, new or worsening fatigue) for pulmonary arterial hypertension; signs/symptoms of thrombotic microangiopathy (eg, new-onset hypertension, thrombocytopenia, renal impairment).

Mechanism of Action

Interferon beta differs from the naturally occurring human protein by a single amino acid substitution and the lack of carbohydrate side chains; alters the expression and response to surface antigens and can enhance immune cell activities. Properties of interferon beta that modify biologic responses are mediated by cell surface receptor interactions; mechanism in the treatment of multiple sclerosis is unknown.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vd: 481 L

Metabolism: Not extensively metabolized in the liver

Half-life elimination: ~78 hours (multiple sclerosis patients)

Time to peak: 1 to 1.5 days

Excretion: Urine (major)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Renal impairment can increase the Cmax and AUC for peginterferon beta-1a. The half-life was 53, 49, and 82 hours in patients with mild, moderate, and severe renal impairment, respectively.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Plegridy;
  • (AT) Austria: Plegridy;
  • (BE) Belgium: Plegridy;
  • (BR) Brazil: Plegridy;
  • (CH) Switzerland: Plegridy;
  • (CL) Chile: Plegridy;
  • (CO) Colombia: Plegridy;
  • (CZ) Czech Republic: Plegridy;
  • (DE) Germany: Plegridy;
  • (ES) Spain: Plegridy;
  • (FR) France: Plegridy;
  • (GB) United Kingdom: Plegridy;
  • (HR) Croatia: Plegridy;
  • (HU) Hungary: Plegridy;
  • (IE) Ireland: Plegridy;
  • (IT) Italy: Plegridy;
  • (KR) Korea, Republic of: Plegridy pen;
  • (LU) Luxembourg: Plegridy;
  • (NL) Netherlands: Plegridy;
  • (PL) Poland: Plegridy;
  • (PR) Puerto Rico: Plegridy;
  • (RU) Russian Federation: Plegridy;
  • (SE) Sweden: Plegridy;
  • (TW) Taiwan: Plegridy
  1. Hunt D, Kavanagh D, Drummond I, et al. Thrombotic microangiopathy associated with interferon beta. N Engl J Med. 2014;370(13):1270-1271. [PubMed 24670186]
  2. MacDonald SC, McElrath TF, Hernández-Díaz S. Use and safety of disease-modifying therapy in pregnant women with multiple sclerosis. Pharmacoepidemiol Drug Saf. 2019;28(4):556-560. doi: 10.1002/pds.4735. [PubMed 30834654]
  3. Mahe J, Meurette A, Moreau A, et al. Renal thrombotic microangiopathy caused by interferon beta-1a treatment for multiple sclerosis. Drug Des Devel Ther. 2013;7:723-728. [PubMed 23950639]
  4. Montalban X, Gold R, Thompson AJ, et al. ECTRIMS/EAN guideline on the pharmacological treatment of people with multiple sclerosis [published correction appears in Eur J Neurol. 2018;25(3):605]. Eur J Neurol. 2018;25(2):215-237. doi: 10.1111/ene.13536. [PubMed 29352526]
  5. Plegridy (peginterferon beta-1a) [prescribing information]. Cambridge, MA: Biogen Inc; July 2023.
  6. Plegridy (peginterferon beta-1a) [product monograph]. Toronto, Ontario, Canada: Biogen Canada Inc; June 2023.
  7. Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology [published correction appears in Neurology. 2019;92(2):112]. Neurology. 2018;90(17):777-788. doi: 10.1212/WNL.0000000000005347. [PubMed 29686116]
Topic 96689 Version 141.0

آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟